PUlmonary REhabilitation in Patients Suffering From Post-PE Syndrome

Not Applicable

Recruiting

• Conditions: Pulmonary Embolism
• Interventions: Other: Rehabilitation

• Registration Number: NCT04615130
• Lead Sponsor: Medical University of Vienna

Brief Summary

This study is a multicenter, parallel, randomized waitlist-controlled trial that primarily focuses on the short-term benefit of outpatient pulmonary rehabilitation (PR) on patients after acute pulmonary embolism.

Patients will be randomized into an intervention and a control group. The intervention group will receive 6 weeks of outpatient PR, while patients in the other treatment arm will serve as a control. After completion of the randomized study, the second arm will undergo PR as well.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-22
• Study First Submitted QC: 2020-10-29
• Study First Posted: 2020-11-04
• Study Start: 2021-06-01
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-21
• Last Update Posted: 2024-03-22
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• Post-PE syndrome (except patients previously diagnosed with CTEPH) diagnosed by any of the following:

  • Post-PE functional impairment criteria
  • Post-PE Cardiac Impairment criteria
  • Chronic Thromboembolic Disease criteria

• Possibility of starting rehabilitation between 12 and 36 weeks after the initial event of PE

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Exclusion Criteria

• CTEPH diagnosis
• Chronic pulmonary diseases: COPD, interstitial lung diseases, asthma (only patients with severe asthma defined as a FEV1 ≤ 80% will be excluded), a statement on COVID-19 was amended due to the pandemic #
• Active cancer
• Pregnancy
• Myocardial infarction or cardiac surgery one year prior to inclusion
• Congenital heart disease, congestive heart failure
• History of stroke
• Any previous inpatient or outpatient PR

Additional criteria that are absolute contraindications for pulmonary rehabilitation

• Acute and decompensated disease states with severe functional restrictions of various organ systems (e.g. heart, kidney and liver insufficiency, unstable angina pectoris, hemodynamically unstable arrhythmias, acute spinal cord injury, untreated hormonal disorders, acute psychological disorders)
• open tuberculosis
• active infectious diseases and acute inflammatory processes
• Stressful and time-consuming therapy that significantly impair the ability to rehabilitate (e.g. chemotherapy or radiation therapy after malignancy)
• Participants who are not sufficiently resilient due to physical or mental impairment and / or cannot be mobilized and therefore cannot actively use the rehabilitation facility
• lack of motivation for therapy
• massive incontinence
• drugs and alcohol addiction

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Rehabilitation	Patients will undergo 6 weeks of outpatient rehabilitation.

Primary Outcome Measures

Name	Time	Method
6-Minute Walk Test	within the 6-week study period	change of walking distance covered within 6 minutes before and after the intervention/control period, measured in meters

Secondary Outcome Measures

Name	Time	Method
peak oxygen consumption	within the 6-week study period	change of peak oxygen uptake (VO2/kg/min) measured by lung spiroergometry
Inspiratory muscle endurance	within the 6-week study period	change in inspiratory muscle endurance measured in seconds
Level of dyspnea	within the 6-week study period	change in dyspea at rest and maximal exertion mesured with the medical research council scale and BORG scale
Health related quality of life	within the 6-week study period	change of quality of life measured with the 5-level EQ-5D version (EQ-5D-5L)
Disease related quality of life	within the 6-week study period	change of quality of life measured with the Pulmonary Embolism Quality of Life (PEmb-QoL)
Functional limitations	within the 6-week study period	change of functional status measured with the patient reported outcomes measurement information system (PROMIS) physical function short form
Functional status	within the 6-week study period	change of functional status measured with the post-VTE functional status scale (min: 0, max: 4, lower scores indicate better functional status)
Anxiety and depression	within the 6-week study period	change in anxiety and depression measured with the hospital anxiety and depression scale (HADS)
One-repetition maximum for lower extremities	within the 6-week study period	change of one-repetition maximum for lower extremities measured in kg
Maximal workload	within the 6-week study period	change of maximal workload in cycle ergometer tests measured in Watt
Maximal inspiratory muscle pressure	within the 6-week study period	change in maximum inspiratory muscle pressure measured in mbar
One-repetition maximum for upper extremities	within the 6-week study period	change of one-repetition maximum for upper extremities measured in kg

Trial Locations

Locations (1)

Therme Wien Med; 🇦🇹 Vienna, Austria